Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized. Roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.
Overview of tissue engineering/regenerative medicine; Cells; Biomaterials for TE/RM products; Neo-Bladder: A foundational technology platform for tubular organ regeneration; Neo-Urinary ConduitA'; Tissue engineering of non-bladder tubular organs; Tissue engineering of solid organs; Regulatory and quality control; Pre-clinical and clinical evaluation of TE/RM products; Manufacturing; Intellectual property.